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FDA 510(k) Application Details - K210820
Device Classification Name
X-Ray, Tomography, Computed, Dental
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510(K) Number
K210820
Device Name
X-Ray, Tomography, Computed, Dental
Applicant
Alliage S/A Industrias Medico Odontol≤gica
Rod. Abrπo Assed, Km 53+450m
Recreio Anhanguera 14097-500 BR
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Contact
Daniel Camargo
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Regulation Number
892.1750
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Classification Product Code
OAS
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More FDA Info for this Product Code
Date Received
03/19/2021
Decision Date
08/10/2021
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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